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Recruiting NCT06764966

Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

Phase II Interventional Decompensated Liver Cirrhosis Cirrhosis Decompensated Cirrhosis of Liver Decompensated Cirrhosis and Ascites

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atorvastatin 20 mg, Placebo.
Who it may be relevant to
Registry conditions: Decompensated Liver Cirrhosis, Cirrhosis, Decompensated Cirrhosis of Liver, Decompensated Cirrhosis and Ascites. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

Overview

Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.

Interventions

  • Drug Atorvastatin 20 mg
    Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker
  • Drug Placebo
    Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

Primary outcome measures

  • Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period [Time frame: 12 months]
  • Feasibility- compare the number of participants compliant with study treatment [Time frame: 12 months]
Secondary outcome measures (6)
  • Safety - Adverse events [Time frame: 12 months]
  • New Decompensating events [Time frame: 12 months]
  • Hepatic transaminases levels [Time frame: 12 months]
  • Survival rate [Time frame: 12 months]
  • Transplant-free survival rate [Time frame: 12 months]
  • Rate of Hepatocellular Carcinoma Diagnosis [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic
  • Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.

Exclusion criteria

  • Any patient <18 years of age
  • Patients with hepatocellular carcinoma
  • Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)
  • Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence
  • Patients currently on statin therapy
  • Patients with a history of statin intolerance
  • Patients on the waitlist for liver transplantation
  • Patients taking medications with known drug interactions with statins
  • Patients not able to give informed consent or patients belonging to vulnerable categories as the Federal Regulations or Common Rule

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Charleston Area Medical Center — Charleston

Identifiers

NCT: NCT06764966 · 24-1117

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗